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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, image processing, radiological
510(k) Number K113543
Device Name ONDEMAND3D
Original Applicant
#504 sj technoville,
gasan-dong 60-19, geumcheon-gu
seoul,  KR 153-710
Original Contact yong ki im
Regulation Number892.2050
Classification Product Code
Date Received12/01/2011
Decision Date 12/16/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No